CLASS I Drug recall · Reported 6 Feb 2013 · FDA Enforcement Report

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg recalled

Vintage Pharmaceuticals is recalling Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, distributed nationwide in the US. The recall was initiated on 6 Dec 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: All that begin with the letter "C" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13

Quantity recalled897,379 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-138-2013
FDA event ID: 63818
Recalling firm: Vintage Pharmaceuticals, Huntsville, AL
Classification: Class I
Status: Terminated
Recall initiated: 6 Dec 2012
FDA classified: 30 Jan 2013
Reported: 6 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Potency & Assay
Drug class: Pain Medication

Timeline

6 Dec 2012	Recall initiated by company
30 Jan 2013	Classified by FDA	+55 days
6 Feb 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

Which lots are affected?

Lot #: All that begin with the letter "C" a) C1160712C, Exp 12/13; b) C0930812A, C1110412A, C1141012B, C1160712A, Exp 12/13; c) C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, Exp 12/13; d) C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, Exp 12/13; e) C0670312A, C0680312A, C0930812B, C0950812C, Exp 12/13; f) C1160712E, Exp 12/13; g) C0950812A, C1110412C, Exp 12/13; h) C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, Exp 12/13; i) C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A, Exp 12/13

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Vintage Pharmaceuticals

All 7

Reported	Class	Recall	Company	Reason	Where
1 Feb 2017Drug	CLASS III	Dexamethasone Elixir, USP, 0.5 mg recalled by Vintage Pharmaceuticals	Vintage Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2015Drug	CLASS II	Lisinopril Tablets, USP, 40 mg, a) bottle recalled	Vintage Pharmaceuticals	Potency & Assay	Nationwide
28 Nov 2012Drug	CLASS I	Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled	Vintage Pharmaceuticals	Potency & Assay	Nationwide
31 Oct 2012Drug	CLASS II	Perphenazine Tablets recalled by Vintage Pharmaceuticals	Vintage Pharmaceuticals	Other	Nationwide
25 Jul 2012Drug	CLASS III	Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/, 1 Pint recalled	Vintage Pharmaceuticals	Potency & Assay	Nationwide

Other Hydrocodone Bitartrate recalls

All 19

Reported	Class	Recall	Company	Reason	Where
15 Dec 2021Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen	Ascent Pharmaceuticals	Packaging Defects	Nationwide
26 May 2021Drug	CLASS III	Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide	Kvk-Tech	Potency & Assay	Nationwide
25 Nov 2020Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled	Ascent Pharmaceuticals	Other	Nationwide
20 Nov 2019Drug	CLASS II	Hydrocodone Bitartrate and Homatropine Methlybromide Oral recalledHydrocodone Bitartrate And Homatropine Methylbromide	Kvk-Tech	Particulate Matter	Nationwide
19 Jun 2019Drug	CLASS II	Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled	Torrent Pharma	Sterility	Nationwide