Cyclobenzaprine Hydrochloride Tablets recall
FDA recall D-0655-2025 · initiated Aug 27, 2025
Unichem Pharmaceuticals USA Inc. recalled Cyclobenzaprine Hydrochloride Tablets in Aug 2025 — an FDA Class I recall (D-0655-2025) because Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 230 90-count bottles
Details
- Product
- Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
- Recalling company
- Unichem Labs Ltd
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S.A
- Initiated
- Aug 27, 2025
- FDA report date
- Sep 24, 2025
Frequently asked
- Was Cyclobenzaprine Hydrochloride Tablets recalled?
- Unichem Pharmaceuticals USA Inc. recalled Cyclobenzaprine Hydrochloride Tablets in Aug 2025 — an FDA Class I recall (D-0655-2025) because Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Cyclobenzaprine Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0655-2025 was: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
- Is a recalled Cyclobenzaprine Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cyclobenzaprine Hydrochloride Tablets are affected?
- Distributed: Nationwide within the U.S.A. The recall covers these lots — Lot No: GMML24026A, Expires: 09/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0655-2025.